Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This application is a US national phase of PCT/US20/31694, filed May 6, 2020 with a provisional application 62/844045, filed May 6, 2019. Applicant’s amendment filed January 30, 2026 is acknowledged. Claims 2-4 and 7-17 are canceled, and claim 1 is amended. Currently claims 1, 5-6, and 18 are pending and under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 4, 2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-6, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Segal et al. (WO 2016/185469 A1, cited in PTO-892 mailed 3/04/2026, hereinafter “Segal”) in view of Li et al. (US 2019/0209626 A1, cited in PTO-892 mailed 10/31/2025, hereinafter “Li”).
Segal teaches methods of improving the glucose response in subjects by providing probiotic compositions or agents which specifically reduce bacterial species (abstract). Segal teaches the probiotic composition comprises at least one Faecalibacterium prausnitzii L2-6 and Bifidobacterium longum sp. longum F8 (pg. 4, lines 22-32, pg. 5, lines 1-6). Segal teaches according to an aspect of some embodiments, providing a probiotic composition comprising at least two bacteria which is categorized as beneficial according to Table 5 (pg. 4, lines 14-17), which lists Bacteroides ovatus as beneficial (pg. 65, col. 2). Segal teaches the probiotic bacteria may be in any suitable form, such as a powdered dry form (i.e. lyophilized) and encapsulated by standard techniques known in the art (pg. 19, lines 24-30). Segal teaches the composition may be in the form of a food product, and comprise a juice, which meets the limitations of claims 5-6, and 18 (pg. 20, lines 4-7).
Segal does not specifically teach Bacteroides ovatus CL03T12C18.
However, Li teaches probiotic compositions comprising at least one bacterium from Bacteroidetes phylum and at least one bacterium from Firmicutes phylum that confer health benefits to the subject (abstract). Li teaches bacteria from Bacteroidetes can be the strain Bacteroides ovatus CL03T12C18 (pg. 6, Table 3, [0060]) and bacteria from Firmicutes can be the species Faecalibacterium prausnitzii, reciting various strains [0051, 0063]. Li teaches the probiotic composition can be formulated for oral administration, such as tablets or capsules [0066].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the strains F. prausnitzii L2-6, B. longum subsp. longum F8, and a Bacteroides ovatus strain, as taught by Segal, and the Bacteroides ovatus CL03T12C18 strain taught by Li, to formulate a nutritional probiotic composition to confer health benefits with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to combine various well-known probiotic strains in a composition as disclosed by the prior art to formulate the health beneficial composition as claimed, since these strains are known to possess similar functions and attributes, thus are interchangeable in probiotic pharmaceutical compositions.
Response to Arguments
Applicant's arguments filed August 4, 2026 have been fully considered but they are not persuasive.
Regarding Remarks directed to the previous 35 U.S.C. 103 rejection, Applicant argues A POSA did not have a reasonable expectation of success at arriving at the claimed invention when Segal and Li are combined. Applicant argues Segal teaches probiotic compositions comprising 1-50 from Table 5, and the fact that a claimed species or subgenus is encompassed by a prior art genus is not sufficient by itself to establish a prima facie case of obviousness. In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994); MPEP 2144.08(II). Applicant respectfully submits that impermissible hindsight and "picking and choosing" elements from a laundry list of bacteria was used in an attempt to arrive at the claimed invention, and there would not have been any reasonable expectation of one of skill in the art successfully doing so. Segal provides no direction that would lead a skilled artisan to successfully select the bacterial strains for use in the composition as claimed from the almost infinite list of bacteria that Segal considers "beneficial.". Applicant argues a POSA would likely be confused from the disclosure of Segal as to what bacteria is considered "beneficial" from the Tables 3-5, as Table 5 asserts that bacteria selected from the Faecalibacterium and Clostridium genus are "non-beneficial" but the Clostridium bartlettii species is considered "beneficial”. See, Segal at Table 5. Therefore, without direction in the Segal reference as to which of the many possible bacterial strains could be considered for a composition, "a defendant [is] merely throw[ing] metaphorical darts at a board filled with combinatorial prior art possibilities, [and] courts should not succumb to hindsight claims of obviousness." In re Kubin, 561 F.3d 1351, 1359-1360 (Fed. Cir. Apr. 3, 2009). Applicant argues Li examined "a total of 3,416 human gut samples, including 2,119 samples from healthy and clinically-symptomatic individuals" (Li [0017]) and arrived at "[a] total of 59 bacterial species [that] were identified as potential probiotics"(Li [0018]) which Li "classified into three phyla: Bacteroidetes, Firmicutes, and Verrucomicrobia" (Li [0019]). Of the 59 bacterial species Li disclosed for use as "potential probiotics," "[t]wenty of the 59 bacterial species were identified to have more than one strains.". Li then provides 101 bacterial strains in Table 3, any combination of which could belong in the compositions taught by Li. Applicant argues Li does not provide any particular guidance as to which, if any, of these bacterial strains are preferred over one another for use in a composition. "Any judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971) (emphasis added). Otherwise, "an obviousness assessment might break an invention into its component parts (A + B + C), then find a prior art reference containing A, another containing B, and another containing C, and on that basis alone declare the invention obvious." See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1275 (Fed. Cir. 2004). Such hindsight reconstruction, "using the invention as a roadmap to find its prior art components, would discount the value of combining various existing features or principles in a new way to achieve a new result-often the very definition of invention.". Applicant argues the Office's statement: "Furthermore, the Examples described in the specification are merely surveying beneficial (pro- and anti-inflammatory) microbes associated with CD, and lists many different species/ strains, including the probiotics in the instant claimed composition" (See Advisory Action) hints that the Office is improperly referring to Applicant's as a blueprint for selecting elements from the prior art. The fact that the Applicant identified certain strains as beneficial does not establish that a POSA would have selected those same strains from among the numerous disclosed alternatives provided by Segal and Li. Applicant argues the Office appears to have plucked Faecalibacterium prausnitzii L2-6, Bifidobacterium longum sp. longum F8, and Bacteroides ovatus from the Segal disclosure without considering the disclosure as a whole. Here, the Office relies on Segal's teaching of a composition comprising Bacteroides ovatus in addition to Faecalibacterium prausnitzii L2-6 and Bifidobacterium longum to arrive at the composition recited by the present claim. Bacteroides ovatus is only recited once in the entirety of Segal - as a "beneficial" bacteria listed in Table 5. Segal, p. 63-65. However, Table 5 provides that Faecalibacterium prausnitzii, Bifidobacterium longum, and bacteria belonging to the Clostridium genus are "non-beneficial" bacteria. Segal, p. 63-65. Indeed, Segal provides compositions for "preventing diabetes or prediabetes in the subject" which include a "pharmaceutical composition comprising as the active agent an agent which specifically reduces the number of bacteria of a phylum, class, order, family, genus or species of bacteria which is categorized as non-beneficial according to Table 5" (Segal, p. 4:18-21) and "a probiotic composition, comprising at least two bacteria of a phylum, class, order, family, genus or species of a bacteria which is categorized as beneficial according to Table 5" (Segal, p. 4:15-1 7).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Segal teaches probiotic compositions useful in improving glucose response, thereby preventing diabetes, and including at least one of F. prausnitzii L2-6 and B. longum F8, and at least one or more beneficial bacteria listed in Table 5, which lists B. ovatus among others (pg. 15, lines 12-15). Segal does not teach the specific B. ovatus strain, but Li teaches probiotic compositions comprising CL03T12C18 and F. prausnitzii that confer health benefits to the subject [0060]. Li teaches a large cohort study identifying prevalence of specific species associated with healthy subjects, and found B. ovatus and F. prausnitzii both at 99% prevalence (table 1). Therefore, it would be well within a POSITA to choose specific beneficial bacteria taught by Segal and Li to formulate probiotic compositions as instantly claimed. Furthermore, the instant claims do not limit the lyophilized composition to only the recited bacterial strains because of the open-ended transitional phrase “comprising” in line 1. Regarding Applicant’s argument of ‘metaphorical darts’, the Examples described in the specification are merely surveilling beneficial (pro- and anti-inflammatory) microbes associated with CD, and lists many different species/strains, including the probiotics in the instant claimed composition, which is a common and routine practice in the art, as taught by both Segal and Li. Similarly, the idea of ‘picking and choosing’ from well-known beneficial strains taught in the prior art are routinely referenced in building surveilling studies to determine beneficial species for probiotic compositions. Segal and Li both are in the field of selecting specific beneficial probiotic strain combinations to improve human health, the same field as the instant, and the mere fact that Applicant has identified a combination of strains already taught in the prior art as a probiotic composition does not render it not obvious because that particular combination was not specifically disclosed by a single reference, but rather that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Therefore, it would have been obvious to one of ordinary skill to select specific beneficial bacteria to formulate into probiotic compositions as instantly claimed, therefore the 103 rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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